- Kite Pharma and Juno Therapeutics, recognized CAR-T front-runners, are aiming for FDA approvals for treatment of blood cancers by next year, reports Reuters.
- Chimeric antigen receptor therapy (CAR-T), also known as T-cell therapy, involves extraction of T-cells from a patient, followed by genetic engineering to render those cells more effective at attacking cancer. The T-cells are then reintroduced into the patient’s body.
- Kite is advancing KTE-C19 for treatment of diffuse large B-cell lymphoma (DLBCL), while Juno is in late-stage clinicals of JCARO15 for treatment of acute lymphoblastic leukemia (ALL).
In 2014, the FDA granted Kite an orphan drug designation for KTE-C19, based on data showing a 92% objective response rate among patients with advanced b-cell malignancies. Kite is now waiting for interim results from a late-stage KTE-C19 trial to confirm earlier response and remission rates.
As for Juno, the company presented data at ASCO showing a 77% complete remission rate for patients with advanced ALL who were treated with JCARO15.
Although there continue to be concerns about the risk of cytokine release syndrome, a potentially fatal, inflammatory adverse event associated with CAR-T, clinical trials are moving forward rapidly and both Kite and Juno hope to gain approvals based on phase 2b studies.
Many researchers in the field see CAR-T as on course to become part of the standard of care for treatment of blood cancers, even though there are manufacturing challenges, as well as other price-related concerns to address.